Iso 9000 Quality Systems Handbook Pqm Online-Books Pdf

ISO 9000 Quality Systems Handbook PQM online
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Quality Systems, Fourth Edition, Completely revised in response to ISO 9000 2000. David Hoyle, OXFORD AUCKLAND BOSTON JOHANNESBURG MELBOURNE NEW DELHI. Butterworth Heinemann, Linacre House Jordan Hill Oxford OX2 8DP. 225 Wildwood Avenue Woburn MA 01801 2041, A division of Reed Educational and Professional Publishing Ltd. A member of the Reed Elsevier plc group, First published 1994.
Second edition 1994, Third edition 1998, Reprinted 1999. Fourth edition 2001, David Hoyle 2001, All rights reserved No part of this publication may be reproduced in. any material form including photocopying or storing in any medium by. electronic means and whether or not transiently or incidentally to some. other use of this publication without the written permission of the. copyright holder except in accordance with the provisions of the Copyright. Designs and Patents Act 1988 or under the terms of a licence issued by the. Copyright Licensing Agency Ltd 90 Tottenham Court Road London. England W1P 0LP Applications for the copyright holder s written. permission to reproduce any part of this publication should be addressed. to the publishers, British Library Cataloguing in Publication Data. A catalogue record for this book is available from the British Library. Library of Congress Cataloguing in Publication Data. A catalogue record for this book is available from the Library of Congress. ISBN 0 7506 4451 6, For information on all Butterworth Heinemann publications visit our website at. www bh com, Composition by Genesis Typesetting Laser Quay Rochester Kent.
Printed and bound in Great Britain, Preface ix, Chapter 1 Introduction 1. Chapter 2 Basic concepts 18, Principles or prescription 18. Quality 19, The interested parties 22, The characteristics of quality 25. Achieving sustaining and improving quality 32, Summary 76. Basic concepts Food for thought 77, Chapter 3 Role origins and application of ISO 9000 80.
The role of ISO 9000 80, Origin of ISO 9000 83, Changes to ISO 9000 91. Exclusions 102, An alternative structure 106, Certification to ISO 9001 2000 111. Summary 113, Role origins and application Food for thought 114. vi Contents, Chapter 4 Quality management system 116. Summary of requirements 116, Establishing a quality management system 117.
Identifying processes 4 1a 121, Sequence and interaction of processes 4 1b 127. Criteria and methods for effective operation and, control 4 1c 128. Documenting a quality management system 4 1 4 2 1 130. Documented procedures 4 2 1c 137, Documents that ensure effective planning operation. and control of processes 4 2 1d 140, Implementing a quality management system 4 1 158. Managing processes 4 1 159, Ensuring information availability 4 1d 164.
Ensuring the availability of resources 4 1d 166, Measuring monitoring and analysing processes 4 1e 167. Maintaining a quality management system 4 1 170, Continual improvement in the QMS and its. processes 4 1 and 4 1f 172, Preparing the quality manual 4 2 2 174. Control of documents 4 2 3 180, Control of records 4 2 1e and 4 2 4 207. Summary 217, Quality Management System Questionnaire 218.
Quality Management System Food for Thought 219, Chapter 5 Management responsibility 222. Summary of requirements 222, Management commitment 5 1 223. Customer focus 5 2 236, Quality policy 5 3 242, Quality objectives 5 4 1 251. Quality management system planning 5 4 2 261, Responsibility and authority 5 5 1 267. Management Representative 5 5 2 273, Internal communication 5 5 3 280.
Management Review 5 6 284, Summary 297, Management Responsibility Questionnaire 297. Management Responsibility Food for Thought 299, Chapter 6 Resource management 302. Summary of requirements 302, Determining resources 6 2 1 304. Contents vii, Providing resources 6 2 1 307, Competence of personnel 6 2 1 310. Training awareness and competence 6 2 2 314, Infrastructure 6 3 329.
Work environment 6 4 336, Summary 349, Resource Management Questionnaire 350. Resource Management Food for thought 351, Chapter 7 Product realization 353. Summary of requirements 353, Planning product realization processes 7 1 356. Customer related processes 7 2 376, Design and development 7 3 401. Purchasing 7 4 449, Production and service provision 7 5 473.
Control of measuring and monitoring devices 7 6 510. Summary 534, Product Realization Questionnaire 535. Product Realization Food for Thought 540, Chapter 8 Measurement analysis and improvement 542. Summary of requirements 542, Monitoring measurement analysis and improvement. processes 8 1 544, Customer satisfaction 8 2 1 553. Internal audit 8 2 2 556, Monitoring and measurement of processes 8 2 3 572.
Monitoring and measurement of product 8 2 4 576, Control of nonconforming product 8 3 584. Analysis of data 8 4 595, Improvement 8 5 609, Summary 640. Measurement analysis and improvement questionnaire 641. Measurement analysis and improvement food for, thought 644. Appendix A Glossary 647, Appendix B Related web sites 658. Preface and acknowledgements, Since the third edition of this handbook was published in 1998 there has been.
a radical change to the ISO 9000 family of standards The standards have. changed in structure from 20 elements to 8 sections they have changed in. intent from quality assurance to customer satisfaction the terminology has. changed so as to suit all types of organizations and there has been a change in. direction from a focus on planning inspection and test and the removal of. nonconformity to a focus on objectives processes measurement analysis and. improvement, This meant that the handbook that had evolved over the previous eight years. required a complete rewrite However I have maintained the basic purpose of. the handbook that of providing the reader with an understanding of each. requirement of ISO 9001 through explanation examples lists tables and. diagrams As there were over 300 requirements in the 1994 version of ISO 9001. this led to a book of considerable size it was not intended as a quick read It. was and remains a source of reference and although I was tempted to. restructure the book as an A Z of ISO 9000 to reduce duplication I have. adhered to following the structure of the standard adding clause numbers to. the headings to make it user friendly The handbook is therefore laid out so as. to follow the section numbers of ISO 9001, Most of the requirements of the 1994 version are included in the 2000 version. of ISO 9001 but few remain exactly the same Many have been reworded or. condensed to remove over prescriptive requirements and focus on general. concepts The differences between the 1994 and 2000 versions are shown in text. x Preface and acknowledgements, boxes by the side of the new requirement In revising this handbook a lot of. detail had to be omitted primarily as it was focused on manufacturing. examples or detail requirements that are no longer included in the standard. Previous versions of this handbook therefore remain relevant and a useful. source of information for those interested in seeking such detail. In the previous editions the approach taken was to identify a requirement and. then explain its meaning followed by some examples to illustrate how it could be. implemented In this new edition I have followed a more structured approach. and for each requirement answered three basic questions What does it mean Why. is it important How is it implemented This is so that the requirements may be. perceived as reflecting concepts valid outside the context of ISO 9000. At the end of each chapter there is a Questionnaire built from the. requirements of the standard It is not intended that these questions be used by. auditors but by users of the standard in order to test the completeness of the. system they have formalized In place of the lists of do s and don ts and the. task list of previous editions I have included a section on Food for Thought This. is intended to cause the reader to reflect on the previous chapter perhaps even. change perceptions but mostly confirm understanding The do s and don ts. and task lists are within the text and will be consolidated in a new edition of. the ISO 9000 Pocket Guide, Throughout the book a common approach has been taken to the require. ments of ISO 9000 This approach is a development of that what was used in. the previous editions The standard has become more generic it now presents. the requirements in a more user friendly format and has adopted the process. approach to management While the requirements of ISO 9001 are expressed in. a way that takes the reader through a cycle starting with the quality policy. leading onto quality objectives and ending with performance being reviewed. against objectives there remain many inconsistencies that could lead to. confusion Many of the linkages between policy objectives processes and. results are inferred they are not expressed unambiguously It is only by. studying ISO 9000 ISO 9001 and ISO 9004 and searching for understanding. that a clear logic emerges The use of the word quality creates an anomaly and. tends to represent the standard as simply a tool to meet customer quality. requirements and no others This is not to say that the standard is flawed It is. only saying that the concepts could be presented more clearly Consequently I. have taken an approach that requires the principles and requirements. contained in the ISO 9000 family to be perceived as general business concepts. and not simply limited to the achievement of quality in its narrowest sense. While the arguments for taking this approach are addressed in the book the. theme of the book is reflected in the following principles. The quality policy exists to shape behaviour and establish the core values in. an organization and therefore equates with the corporate policy no benefits. are gained from specifically expressing a quality policy and ignoring other. Preface and acknowledgements xi, policies because all policies influence the behaviours that are key to satisfying.
the needs of interested parties, Quality is a strategic objective that is established to fulfil the needs and. expectations of all interested parties and therefore equates with the corporate. objectives no benefits are gained from ranking quality equally with other. objectives, The quality management system is the management system that enables the. organization to fulfil its purpose and mission Consequently in this handbook. the term management system is used throughout except when referring to the. requirements of the standard rather than terms quality system quality. management system or simply QMS Organizations have only one system no. benefits are gained from formalizing part of a system that focuses on quality. By dropping the word quality from this term it is hoped that the reader will. begin to perceive a system that is significantly more beneficial than the quality. system addressed by ISO 9000 1994, The adequacy suitability and effectiveness of the management system is judged. by how well the system enables the organization to achieve its objectives. operate efficiently and fulfil its purpose and mission no benefits are gained. from simply focusing on one aspect of performance when it is a combination. of factors that deliver organizational performance. If you read the handbook from cover to cover you will discover that these. principles are repeated regularly throughout in one form or another Hopefully. this is not too irritating but the handbook is intended as a reference book and. I felt that the alternative of frequent cross references would be just as irritating. However we rarely learn by a chance observation and it often requires. frequent exposure to ideas presented in different forms and context before our. beliefs or perceptions are changed, The first three chapters provide background information with the sub. sequent five chapters dealing with the sections of ISO 9001 that contain the. requirements In this way the chapter numbers of the book mirror the section. headings of the ISO 9001, Chapter 1 addresses the issues that have arisen in the use of ISO 9000 the.
various perceptions surrounding the standard and the associated infra. structure as well as some of the negative influences and misconceptions This. sets the scene for the approach taken in the remainder of the book. Chapter 2 is a revised and much enhanced chapter on basic concepts The. opportunity has been taken to place the more general concepts and principles. in this chapter and provide greater alignment with the topics covered by the. standard Following the style of the first edition I have included management. theory drawn from authors in the field of both general management and. quality management, Chapter 3 addresses the role of the family of standards and answers. frequently asked questions about its purpose uses application and origin. xii Preface and acknowledgements, Having discovered the misconceptions surrounding the use of the standard I. was prompted to explore a little more of the history not of the standard itself. but of the concepts that are expressed in the standard and applied to its use. Many criticize the standard for the burden of bureaucracy that has arisen since. its introduction but what I have found is that ISO 9000 is not a cause but a. ISO 9000 Quality Systems Handbook Fourth Edition Completely revised in response to ISO 9000 2000 David Hoyle OXFORD AUCKLAND BOSTON JOHANNESBURG MELBOURNE NEW DELHI Butterworth Heinemann Linacre House Jordan Hill Oxford OX2 8DP 225 Wildwood Avenue Woburn MA 01801 2041 A division of Reed Educational and Professional Publishing Ltd A member of the Reed Elsevier plc group First published

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